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Maine law requires manufacturers or labelers of prescription drugs to list information on clinical trials on prescription drugs that have been FDA-approved for marketing and are (or have been) dispensed, administered, delivered or promoted in Maine. For information, see: Clinical Trials. Maine Center for Disease Control, Department of Health and Human Services. Accessed on 2009-02-10 at: http://www.maine.gov/dhhs/boh/clinical_trials.htm
Maryland Code, Title 13 – Miscellaneous Health Care Program, Subtitle 20 – Human Subject Research
§ 13-2001. Definitions.
(a) In general.– In this subtitle the following words have the meanings indicated.
(b) Federal regulations on the protection of human subjects.–Federal regulations on the protection of human subjectsmeans:
(1) Title 45, Part 46 of the Code of Federal Regulations, and any subsequent revision of those regulations; and
(2) With respect to research that is subject to the jurisdiction of the federal Food and Drug Administration, Title 21, Parts 50 and 56 of the Code of Federal Regulations, and any subsequent revision of those regulations.
(c) Human subject.–Human subjecthas the meaning stated in the federal regulations on the protection of human subjects.
(d) Institutional review board.–Institutional review boardhas the meaning stated in the federal regulations on the protection of human subjects.
(e) Research.–Researchhas the meaning stated in the federal regulations on the protection of human subjects.
[2002, ch. 552.]
§ 13-2002. Compliance with federal regulations; scope.
(a) Compliance with federal regulations.– A person may not conduct research using a human subject unless the person conducts the research in accordance with the federal regulations on the protection of human subjects.
(b) Scope to include all research.– Notwithstanding any provision in the federal regulations on the protection of human subjects that limits the applicability of the federal regulations to certain research, subsection (a) of this section applies to all research using a human subject.
[2002, ch. 552.]
§ 13-2003. Institutional review board minutes.
(a) Availability.– An institutional review board shall make the final minutes of a meeting available for inspection within 30 days of receipt of a request for the minutes from any person.
(b) Redaction of confidential or privileged information.– Prior to making the minutes of a meeting available for inspection under subsection (a) of this section, an institutional review board may redact confidential or privileged information.
(c) Minutes not public records.– The minutes of a meeting of an institutional review board are not public records under Title 10, Subtitle 6 of the State Government Article.
[2002, ch. 552.]
§ 13-2004. Injunctive or other relief for violations.
(a) In general.– The Office of the Attorney General may seek appropriate injunctive or other relief to prevent the conduct of human subject research in violation of the federal regulations on the protection of human subjects or this subtitle.
(b) Exceptions.– In exercising the authority granted under subsection (a) of this section, the Office of the Attorney General may not:
(1) Duplicate the investigational, compliance, or enforcement action undertaken by an agency of the federal government; or
(2) Bring an action under subsection (a) of this section if an agency of the federal government has determined that an investigation is not warranted.
[2002, ch. 552.]
Maryland Code Online (Michie-Lexis) accessed on 2004-01-09 from http://184.108.40.206/maryland/lpext.dll?f=templates&fn=fs-main.htm&2.0
Background on Maryland House Bill 917
Information: Maryland House Bill 917 Human Subject Research — Institutional Review Boards. State of Maryland General Assembly. Available from http://mlis.state.md.us/2002rs/billfile/hb0917.htm. Adopted 2002-10-01.
Maryland Law on Human Subjects Research. Maryland Office of the Attorney General. Available from http://www.oag.state.md.us/Healthpol/humansubject.htm. (2002-10-01)
Susko MA. CIRCARE Testimony in Support of Maryland House Bill 917 Human Subject Research — Institutional Review Boards. Available from http://www.circare.org/submit/40302MSt.pdf. (2002-04-03)
Medical Research Bill Opposed at Hearing. Tom Pelton. The Baltimore Sun. 2002-03-15.
Senate OKs Bill to Tighten Rules on Human Research. David Nitkin. The Baltimore Sun. 2002-04-06.
Researchers must ensure woman didn't die in vain. Michael A. Susko. The Baltimore Sun. 2001-07-25.
New Maryland Law: The passage of H.B. 917. CIRCARE InfoMail. 2002-06-20. Available from http://www.circare.org/im/im20May2002.htm
Maryland Legislation Cont.
Maryland Senate Bill 681 and House Bill 54: Health – Clinical Trials Data Bank. Requiring a clinical trial to be listed in the Clinical Trials Data Bank of the U.S. Department of Health and Human Services before a sponsor may enroll participants in the clinical trial; prohibiting requirements pertaining to the Clinical Trials Data Bank from affecting existing statutory requirements; authorizing the Attorney General, in specified circumstances, to seek relief to prevent the conduct of a clinical trial and to petition a court to impose a fine; establishing criminal penalties; etc. Available from http://mlis.state.md.us/2005rs/billfile/sb0681.htm. Adopted 2005-04-09.
Maryland Senate Bill 289: Human Subject Research – Clinical Trials. Requiring institutional review boards to approve clinical trials only if the results of the clinical trials will be made available to the public and the clinical trials are registered with a specified data bank. Available from http://mlis.state.md.us/2005rs/billfile/sb0289.htm. Withdrawn 2005-03-14.
Being updated 2006-04-20.
Being updated 2006-04-20.
Access to Medical Research Act, N.J. Laws 2007 c. 316 (26:14-1 26:14-5). 2008-01-13 (approved). Accessed on 2009-02-10 at: http://www.njleg.state.nj.us/2006/Bills/AL07/316_.PDF
N.J.A.C. 13:35-6.7 Minimum Standards for the Performance of New or Novel Procedures in Office Setting. Effective Date: November 7, 2005.
Adopted New Rule: N.J.A.C. 13:35-6.7
Minimum Standards for the Performance of New or Novel Procedures in the Office Setting
Proposed: October 4, 2004 at 36 N.J.R. 4367(a).
Adopted: April 13, 2005 by the Board of Medical Examiners, Bernard Robins, M.D., President.
Filed: September 27, 2005 as R.2005 d.360, with substantive and technical changes not requiring additional public notice and comment (see N.J.A.C. 1:30-6.3).
Effective Date: November 7, 2005.
Expiration Date: March 17, 2010.
Summary of Agency-Initiated Changes:
There was a typographical error in N.J.A.C. 13:35-6.7(d)4 as the rule was proposed. The termsacrificein this rule should have beenscientific.The Board has corrected this error upon adoption.
Federal Standards Statement
The adopted new rule will require licensees who perform new or novel procedures in an office setting to establish a procedural protocol that provides for protections of human subjects consistent with FDA guidelines set forth in 21 CFR § 50 (2004). The Board does not believe that there are any other Federal laws or standards applicable to this adopted new rule.
Full text of the adoption follows (additions to proposal indicated in boldface with asterisks *thus*; deletions from proposal indicated in brackets with asterisks *[thus]*):
13:35-6.7 Minimum standards for the performance of new or novel procedures in the office setting
(a) This section contains minimum standards for the performance of new or novel procedures as defined in (b) below which are performed in the office setting and are not performed under the jurisdiction of an Institutional Review Board (IRB) which complies with the requirements of the Federal Food and Drug Administration.
(b) The following words and terms when used in this section shall have the following meanings, unless the context indicates otherwise:
Diagnostic or therapeutic modalitymeans a modality intended for use in the diagnosis of disease or conditions in humans or in the cure, mitigation, treatment or prevention of disease in humans or a modality intended to affect the structure of or any function of the human body.
Generally recognized as safe and effectivemeans there exists substantial evidence by means of at least two well-controlled clinical studies that the new or novel procedure will have the effect that is represented and the procedure does not pose a significant risk to the physical or emotional health of the patient and has a low reported incidence of adverse reactions or significant side effects.
New or novel proceduremeans a diagnostic or therapeutic modality performed by a Board licensee that:
1. Is not yet generally recognized as safe and effective by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its intended use and poses a potential risk of physical or emotional harm to a patient; or
2. Is a new application of a procedure which has been generally recognized as safe and effective for its traditional use but is not yet generally recognized as safe and effective by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its new application and the new application poses a potential risk of physical or emotional harm to a patient.
*New or novel proceduredoes not include responses to emergent and unexpected issues that arise during surgery or the use of a medication that has been approved by the Food and Drug Administration (FDA), even if the medication is being used for a purpose not specifically approved by the FDA.*
Office settingmeans a location at which medical, surgical or podiatric services are rendered and is not licensed by the New Jersey Department of Health and Senior Services.
(c) A licensee shall not perform a procedure in an office setting that is generally recognized as ineffective and unsafe by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its intended use.
(d) A licensee shall establish a procedural protocol prior to performing a new or novel procedure in the office setting. The protocol shall at a minimum:
1. Provide for protection of human subjects consistent with FDA guidelines set forth in 21 C.F.R. § 50 (2004) available from the United States Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-0001, which are incorporated by reference herein, and as may be amended and supplemented;
2. Ensure the procedure is performed by physicians qualified by training, education, or experience to perform such procedure;
3. Ensure the physician performing the procedure is able to demonstrate the scientific merits of the procedure;
4. Ensure the procedure is supported by adequate and well-controlled animal studies or the weight of the *[sacrifice]* *scientific* and medical literature;
5. Contains provisions for pre-operative screening;
6. Delineate specific diagnoses for which the procedure is indicated;
7. Delineate specific contraindications to the procedure, if any;
8. Provide for fully informed consent in accordance with prevailing New Jersey law, including full explanation of risks, benefits, alternative treatments and likely outcome without treatment;
9. Provide for and demonstrate operator and staff training, experience, and ongoing competency;
10. Provide for a period of post procedure observation and management commensurate with the complexity, invasiveness and risks of the procedure and any concomitant anesthesia;
11. Provide for written discharge instructions, follow-up and any associated aftercare;
12. Maintain documentation of complete care rendered in accordance with Board rules, N.J.A.C. 13:35-6.5, and maintain records of any associated morbidity, mortality and clinical outcomes;
13. Ensure that procedures are described with specificity including use of pharmaceutical agents and their dosages, anticipated side effects, and projected short and long-term treatment; and
14. Where applicable, ensure compliance with the rules regarding surgery and anesthesia services performed in an office setting (N.J.A.C. 13:35-4A).
(e) A licensee shall provide the Board with a procedural protocol upon request in order to ensure that the licensee has complied with the requirements of (d) above.
(f) If the requirements of (d) above cannot be met, a licensee may request Board approval to perform a new or novel procedure. Such request shall include a statement identifying which protocols in (d) above cannot be met and the reason therefor. The Board shall not approve a request under this subsection unless the licensee demonstrates to the satisfaction of the Board that:
1. The procedure may be effective for its intended use and will not expose patients to an unreasonable and significant additional risk of illness or injury;
2. The procedure is intended to treat a serious or immediately life-threatening disease and no comparable or satisfactory therapeutic alternatives are available to treat that stage of the disease in the intended patient population and there is a reasonable likelihood that death will occur within a matter of months or premature death is likely without early intervention;
3. The procedure is under investigation in controlled clinical trials or all clinical trials have been completed but not yet reported; and
4. The licensee has provided to the Board all information known to the licensee, regarding the studies referred to in (f)3 above.
Accessed on 2006-04-20 from http://www.njconsumeraffairs.com/adoption/bmedo117.htm
Last Updated: 2009-02-12
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